Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
1 other identifier
interventional
134
1 country
1
Brief Summary
Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures. Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedOctober 15, 2019
October 1, 2019
3 months
October 1, 2019
October 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Children Fear Scale
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated
1 minute
Wong Baker Face Pain Scale
The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').
1 minute
Study Arms (4)
music group
EXPERIMENTALThe children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over.
kaleidescope group
EXPERIMENTALThe children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
video group
EXPERIMENTALThe children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over.
control group
NO INTERVENTIONNo intervention was made to children in the control group
Interventions
The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over
The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over
The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over
Eligibility Criteria
You may qualify if:
- being healthy
- ability to express himself/herself verbally
- no analgesic taken in the last 6 hours
- having no visual or auditory problems
You may not qualify if:
- chronic disease
- mental disease
- neurological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adiyaman University
Adıyaman, 02100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 3, 2019
Study Start
August 1, 2018
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
October 15, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share